- Prepare and distribute the global Clinical Trial Application dossier and subsequent substantial amendments to country applicants and CROs for submission to ECs and HAs.
- Prepare the data required in CTIS for global Clinical Trial Application dossiers and their subsequent substantial modifications.
- Manage the CT Amendment log considering the EU Regulation and determine windows of opportunity for submissions, escalate within BMS if needed
- Provide support to the Submission Senior Manager/collaborate with the Submission.
- Specialist in CTA preparation activities for initial filings and start up activities, protocol amendments, end of trials and CSR distributions.
- Ensure consistency of the Clinical Trial application across projects, studies and countries.
- Lead Program/Study level CTA Tracking Meetings, in preparation of the CTA dossier, ensuring timelines and dossier quality are managed according to expectations.
- Liaise with country offices and central team (Clinical Supply Operations, Operation Leads, Protocol Managers, Medical Monitor, Safety, Quality Person) to ensure that Clinical trial application activities are in compliance with study timelines, BMS SOPs, worldwide regulatory guidelines and regulations.
- Comply with the use and maintenance of the available planning & tracking tools (e.g. Veeva - HA submission and approval Tracking system) to generate reports and track the CTA content and associated dates.
- Escalate to study teams and GSM-CT senior roles observed trends and issues that may impact timely and successful study approval and execution.
- Contribute to the Global Country Requirements Repository by collecting and sharing additional country requirements.
- Support initiatives for innovation and simplification in the processes to improve the support to the study teams and GSM-CT.
- Expected to be able to coordinate updates within a Program.
- Support continuous improvement and compliance initiatives.
- Utilizes technology effectively to support the clinical trial application submission process. Proficient use of CTMS, Tracking systems, Excel trackers, to generate reports and track the CTAp content and associated dates.
- Contributes to other requirements as appropriate to allow proper functioning of the GSM-CT.
- Support implementation of the EU CT REG Portal from Feb 2022.
- Provide training/mentoring to the GSM-CT newcomers.
- BA/BS degree, science / technology field preferred
- Demonstrated relevant regulatory submissions experience
- Expert knowledge of Regulatory Submissions and package content for non-US clinical trial applications to health authorities.
- Assists in the development of short- and long-term goals for own workgroup in alignment with those of GSM and the R&D umbrella.
- Resolves problems/difficulties with the assistance of Sr. team members.
- Supports other functions as appropriate.
- Independently facilitate compound/study team meetings.
- Works Independently and collaborates with other functional areas.
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Clinical Trial Administrator
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Hobson Prior Uxbridge, United KingdomHobson Prior are currently looking for a Senior Clinical Trial Management Associate to join a brilliant biotech establishment on a contract basis. Our client is focused on producing a healthier world. · Please note that to be considered for this role you must have the right to wo ...
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Senior Specialist, Submission Management, Clinical Trials - Uxbridge, United Kingdom - Bristol Myers Squibb
Description
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more:
The Submission Specialist, Clinical Trials manages and coordinates the timely, compliant, and accurate delivery of the core submission documents and dossiers to BMS HA/EC Applicants and CRO.The Senior Specialist also participates in the preparation of the CTIS for CT under the EU Regulation.
Position Responsibilities
Experience Requirements
#LI-Hybrid
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through scienceTM ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Bristol Myers Squibb is Disability Confident – Committed
A UK Government scheme
